NCT05802485尚未招募不适用
PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT: PANDORE-PANC-IPC 2021-082
Institut Paoli-Calmettes0 个研究点目标入组 300 人开始时间: 2023年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma
研究概览
简要总结
The study consists of a 25 ml blood sample collection:
- Before the start of treatment
- Approximately 2 months after the start of induction chemotherapy
- At the end of induction chemotherapy
- Prior to local treatment (radiotherapy, surgery)
- At the time of tumor progression
Collection of tumor material:
- During the initial diagnostic biopsy
- On the operating room in case of surgery
- At tumor biopsy in case of recurrence or progression (optional) As well as the completion of a questionnaire at inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-metastatic pancreatic adenocarcinoma that is not immediately resectable (borderline and locally advanced tumors according to the NCCN 2020 classification)
- •No previous treatment with surgery or chemotherapy
- •Age > 18 years
- •General condition WHO 0-2 (patient whose general condition can allow medical treatment or surgery)
- •Therapeutic management at the Paoli-Calmettes Institute
- •Signature of the informed consent specific to the PANDORE-PANC study
- •Patient affiliated to a social security system or benefiting from such a system
排除标准
- •Metastatic disease
- •Pancreatic tumor of a histological type other than adenocarcinoma
- •Other tumor under treatment or for which treatments have been completed for < 1 year
- •Pregnant or breastfeeding women
- •Person in an emergency situation
- •Person of legal age under legal protection (guardianship, curatorship or safeguard of justice) or unable to give consent.
研究组 & 干预措施
collection of blood and tumor samples
Other
干预措施: collection of blood and tumor samples (Other)
结局指标
主要结局
Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma
时间窗: up to 6 years
Analysis of the impact of identified biomarkers on overall patient survival and tumour response
次要结局
未报告次要终点
研究者
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